ABILITY OF PROLONGED RELEASE TACROLIMUS, TAKEN ONCE DAILY, IN MAINTAINING REMISSION OF CALCINEURIN INHIBITOR DEPENDENT STEROID SENSITIVE NEPHROTIC SYNDROME IN CHILDRE

Not Applicable

• Conditions: Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality

• Registration Number: CTRI/2022/01/039427
• Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Idiopathic steroid-sensitive nephrotic syndrome

2. CNI dependent nephrotic syndrome, as defined by all of the following: (i) frequent relapses or

steroid dependence; (ii) failure of two or more immunosuppressive agents; (iii) sustained remission

or infrequent relapses during therapy with CNI

3. Therapy with oral tacrolimus twice daily for 6-30 months

4. Tacrolimus 12-hr trough level of 4-7 ng/mL

5. No or one relapse in the last 6 months

6. Currently in remission

7. Written informed consent

Exclusion Criteria

Secondary nephrotic syndrome

Steroid resistant nephrotic syndrome

Histology other than minimal change disease, focal segmental glomerulosclerosis or

mesangioproliferative glomerulonephritis

Frequent relapses during therapy with tacrolimus

Therapy with either CNI for a cumulative duration of >30 months

Therapy with immunosuppressive agents other than prednisolone and tacrolimus in the past 6

months (e.g., cyclosporine, rituximab, mycophenolate mofetil or cyclophosphamide)

Estimated glomerular filtration rate (eGFR) less than 60 ml/min per 1.73 m2

Infection with hepatitis B or C or HIV

Seizures or recurrent headache during therapy with tacrolimus

Concomitant therapy with an agent that interferes with bioavailability of tacrolimus Glycosylated hemoglobin (HbA1c) >5.7% or fasting blood glucose >100 mg/dL

Hypomagnesemia despite therapy with magnesium oxide (<= 1.7 mg/dL)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with stable remissionTimepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
Change in estimated GFR, HbA1c, and total and LDL cholesterolTimepoint: 6 months;Number of relapsesTimepoint: 6 months;Proportion with treatment failureTimepoint: 6 months;The proportion of children with sustained remission <br/ ><br>Timepoint: 6 months;Total daily dose to trough ratio changeTimepoint: after 6 months of therapy